1. Field of the Invention
The present invention relates generally to a device and method for controlling urinary incontinence of a male subject and more particularly to an inflatable cuff for restricting the urethral passageway and associated method for incontinence control.
2. Description of the Related Art
Male urinary incontinence is a long-recognized medical condition that poses an embarrassment to men whose urethral valves or sphincters are no longer capable of controlling the flow of urine from the bladder. Urinary incontinence can arise from a variety of causes, including disease, surgery, neurological dysfunction, malformation of the urethral valve, physical deterioration incident to advancing age, as well as various other causes. Externally applied absorbent pads and internal catheters connected to collection bags are currently used as solutions to the problem of incontinence. Such solutions, however, ultimately entail the external collection of the urine that escapes the bladder. Collection devices heretofore used for urine collection are frequently uncomfortable, inconvenient, unsanitary, offensive, unreliable and even inadequate during use.
Commonly employed non-invasive devices for the control of male incontinence include straps, bands, clamps, cradles, or other members that encircle the shaft of the penis. Devices of this type are positioned about and tightened around the shaft of the penis until sufficient pressure has been applied to the urethra and the corpus spongiosum to substantially and preferably completely close the urethra. The device is loosened or removed to permit the flow of urine through the urethra when appropriate.
The non-invasive type devices known in the art for controlling male incontinence can be flexible or rigid and frequently include a projection intended to lie beneath and apply a sealing pressure to the urethra and corpus spongiosum. The projection can be rigid or resilient, or can even be an inflatable sac. See, for example, U.S. Pat. Nos. 4,800,900, 5,984,910, 6,463,932. Inflatable sacs are also disclosed in erectile maintenance devices. See, for example, U.S. Pat. Nos. 5,295,946, 5,370,601, and 6,015,379.
Incontinence control devices of the encirclement type are designed to permit sufficient tightening of the device around the shaft of the penis, to prevent or substantially reduce the leakage of urine through the urethra. Unfortunately, sufficient tightening of the encirclement type device almost invariably results in the application of an excessive and not infrequently painful amount of pressure to tissues other than the urethra and corpus spongiosum. In particular, virtually all devices of this type apply undue pressure to the superficial dorsal vein, the deep dorsal veins, and the dorsal arteries and nerves. Accordingly, to avoid injury, such devices must be removed numerous times per day in order to reduce the applied pressure and allow proper blood flow.
Further, these male incontinence control devices do not always provide sufficient pressure to keep the urethra in a closed position. In particular, the penis and the urethra are both very flexible, and as such, the urethra can change location within the penis itself. Because prior devices employ means for applying preferential pressure to particular points on the penile shaft, any movement or improper positioning of the device along the shaft can result in an improperly closed or pinched urethra and the undesired occurrence of urine leakage.
Compressive encirclement devices for male incontinence control are subject to other drawbacks as well. Some are relatively complex in construction, and therefore relatively expensive to manufacture. Some provide poor adjustability to the particular patient using them. Further, many of these devices are very large and cumbersome. The size and weight of these devices results in such discomfort that the user is not able to wear the device for extended periods of time.
In light of the above, there is a continuing need for an improved device for controlling male urinary incontinence, which avoids applying undue pressure to the veins, arteries, and nerves of the penis shaft, while ensuring that sufficient pressure is applied to the urethra and the corpus spongiosum to prevent or substantially reduce leakage from the urethra. The desired device would avoid inflicting pain, trauma and/or damage to the skin and underlying tissues of the penile shaft when used, and preferably could be comfortably worn by the patient for extended periods of time, e.g., an entire day without removal, except for urination. There is a need for a device of such type that is relatively inexpensive in construction, easy to clean, and relatively easy to properly position on the penile shaft and to release for urination.
The present invention relates to a device and method for controlling urinary incontinence of a male subject.
In one aspect, the present invention relates to a male urinary incontinence control device comprising an inflatable cuff including a sealable interior volume having a valve associated therewith.
In another aspect, the present invention relates to an inflatable cuff adapted to slip over the glans of a penis wherein the inflatable cuff encircles the shaft of the penis along the longitudinal axis of the shaft. The inflatable cuff comprises an inner layer and an outer layer connected to form a sealable interior volume and a valve for introducing a fluid, such as air, into the sealable interior volume. The sealable interior volume comprises a plurality of inflatable interconnected passages arranged parallel to one another along the longitudinal axis of the cuff. In one embodiment, at least one of the inflatable passages comprises a rigid member wherein the rigid member extends along the longitudinal axis of the cuff. The outer layer of the inflatable cuff is substantially non-distensive and the inner layer is distensive and provides a variable inner diameter. Upon introduction of fluid into the inflatable passages, the variable inner diameter of the inner layer is reduced, thereby causing an increase in the circumferential pressure on the shaft of the penis, concomitantly closing the urethra and corpus spongiosum and preventing leakage.
In yet another aspect, the present invention further comprises an occlusive sac that is integrated into the inflatable cuff structure, for applying preferential pressure ventrally to the urethra and corpus spongiosum of the penis.
The present invention in another aspect further comprises a hand pump for inflating the sealable interior volume of the inflatable cuff. In a particularly preferred embodiment, the hand pump circumscribes the outer layer of the inflatable cuff, forming a unitary cuff-pump structure, wherein the hand pump means are communicatively connected to the valve of the inflatable cuff.
In a further embodiment, the inflatable cuff further is constructed and arranged for coupling to an external catheter for transporting urine from the penis to a collection container. The external catheter is preferably matably and removably attached to a distal end of the cuff.
The invention also relates in another aspect to a method of controlling urinary incontinence utilizing a device of a type as variously described above.
Other aspects, features and embodiments of the invention will be more fully apparent from the ensuing disclosure and appended claims.